Healthy AdultHRIPTNCT07473661
Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers
A study testing Collagen-Based Material in people with Healthy Adult, run by SerenaGroup, Inc. at 1 site in United States.
Trial summary
This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Collagen-Based Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 70 years
- Male and female participants
- Fitzpatrick Skin Types I and VI
- Participants of any race
- Participants of any ethnicity (Hispanic or Latino or Not Hispanic or Latino)
- Generally healthy, without dermatological or systemic conditions that could interfere with study participation or evaluation of results, as determined by the investigator
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- Able to read and understand English and provide written informed consent
- Able to comply with study procedures and complete all required visits
- Willing to have test materials applied according to the study protocol
- Has not participated in a similar clinical study within the previous 30 days
- Agrees to avoid excessive sun exposure, sunbathing, or tanning during study participation
- Female participants of childbearing potential willing to undergo pregnancy testing prior to participation
- Agrees not to change current personal care products during study participation
Who cannot join
- Use of medications that may interfere with study results (e.g., corticosteroids, antihistamines, immunosuppressive agents, or high-dose NSAIDs)
- History of acute or chronic medical conditions that could interfere with study participation or increase risk (e.g., autoimmune disease, HIV infection)
- Chronic skin conditions such as atopic dermatitis or eczema
- Treatment for skin cancer within the previous 12 months
- Abnormal or damaged skin at test sites that could interfere with evaluation (e.g., sunburn, tattoos, scars, active dermatologic conditions)
- Diabetes requiring insulin therapy
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- Pregnant, planning pregnancy, or breastfeeding
- Known hypersensitivity to personal care products, cosmetics, fragrances, or adhesives
- Known fish allergy
- Any condition that, in the opinion of the investigator, may compromise participant safety or study integrity
Trial locations and contacts
1 site in 1 country.
United States1 site
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
About this study
Official title: Human Repeat Insult Patch Test (HRIPT): Assessment of Skin Irritation and Sensitization of a Collagen-Based Material in Healthy Volunteers
This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.
- Conditions
- Healthy Adult
- Being tested
- Collagen-Based Material
- Keywords
- skin irritation, skin sensitization, HRIPT, Fibrous Collagen Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen-Based MaterialDevice
A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants.
| Study group | Role | What they receive |
|---|---|---|
| Human Repeat Insult Patch Test Procedure | Experimental | Participants will undergo repeated occlusive patch applications of a collagen-based material to assess skin irritation and sensitization in healthy adult volunteers. Receives: Device: Collagen-Based Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale
Dermal irritation response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4).
Measured: During the induction phase (approximately 3 consecutive weeks)
Secondary outcomes (1)
Allergic Contact Sensitization Response Using ICDRG Scale
Allergic contact sensitization response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4) following challenge exposure
Measured: Through completion of all skin assessments during the study (approximately 5-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start27 Feb 2026
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473661
- Sponsor's protocol ID
- Pro00093062
- Acronym
- HRIPT
- Status last verified
- May 2026
- First submitted
- 4 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Repeat Insult Patch Test (HRIPT): Assessment of Skin Irritation and Sensitization of a Collagen-Based Material in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07473661
- Acronym / sponsor ID
- HRIPT / Pro00093062
- Conditions
- Healthy Adult
- Keywords
- skin irritation, skin sensitization, HRIPT, Fibrous Collagen Matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Repeat Insult Patch Test Procedure | Experimental | Device: Collagen-Based MaterialParticipants will undergo repeated occlusive patch applications of a collagen-based material to assess skin irritation and sensitization in healthy adult volunteers. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged 18 to 70 years
- Male and female participants
- Fitzpatrick Skin Types I and VI
- Participants of any race
- Participants of any ethnicity (Hispanic or Latino or Not Hispanic or Latino)
Key exclusion criteria (10 listed)
- Use of medications that may interfere with study results (e.g., corticosteroids, antihistamines, immunosuppressive agents, or high-dose NSAIDs)
- History of acute or chronic medical conditions that could interfere with study participation or increase risk (e.g., autoimmune disease, HIV infection)
- Chronic skin conditions such as atopic dermatitis or eczema
- Treatment for skin cancer within the previous 12 months
- Abnormal or damaged skin at test sites that could interfere with evaluation (e.g., sunburn, tattoos, scars, active dermatologic conditions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen-Based MaterialA collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants. | Device | Human Repeat Insult Patch Test Procedure |
Primary outcome
Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale
Time frame: During the induction phase (approximately 3 consecutive weeks)
Dermal irritation response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4).
1 secondary outcome
Allergic Contact Sensitization Response Using ICDRG Scale
Time frame: Through completion of all skin assessments during the study (approximately 5-6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen-Based Material in people with Healthy Adult, run by SerenaGroup, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale (time frame: During the induction phase (approximately 3 consecutive weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.